Residues in antibiotic preparations, ii: effect of pH on the nature and level of particulate matter in sodium cephalothin intravenous solutions

Abstract

The effect of pH on the extent and nature of particulate contamination in sodium cephalothin intravenous solutions was studied. The extent of particulate contamination was determined by microscopic and automatic electronic counting procedures, and the physical nature of the particles was determined using scanning electron microscopy. At low pH values (i.e., 4.9--5.9), an amorphous residue was predominant, while at higher pH values (6.9--7.8), the gelatinous nature of the residue disappeared and small crystalline particulates of varying sizes were predominant. The level of particulate contamination (particles over 10 mum in size) decreased with an increase in pH to a minimum level between pH 7 and 8. Advice is given to practitioners regarding the preparation of sodium cephalothin solutions.